Self-described female-founded oncology company Phoenix Molecular Designs has started dosing in the Phase II arm of a trial examining its metastatic breast cancer candidate, PMD-026.
The Phase I/Ib/II trial (NCT04115306) is moving on to its third part which will see the oral ribosomal s6 kinase (RSK) inhibitor examined in combination with fulvestrant in HER 2, +HR and RSK2-high breast cancer patients.
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The Phase II portion of the study will include 14 new patients and six patients who have been in the earlier stages of the study across eight clinical sites across the US. The Dauntless-1 trial aims to extend the impact of commonly prescribed breast cancer second-line endocrine therapy fulvestrant, a selective oestrogen receptor degrader (SERD). Phoenix says that PMD-026 is highly synergistic with fulvestrant in preclinical models.
The same study has already evaluated the drug at Phase I/Ib, which evaluated PMD-026 as both a monotherapy and a combination therapy in 41 patients. As a combination therapy, it was found to be safe and well tolerated.
Phoenix’s chief medical officer Brian Barnett said: “We are enthusiastic about PMD-026’s clinical development and the potential to address an area of significant clinical unmet medical need in breast cancer patients with advanced HR+/HER2- breast cancer who have previously been treated with a CDK4/6 inhibitor by providing a novel targeted therapy in combination with a standard of care endocrine therapy.”
Typically, HER2 is the protein that controls the development of breast cell growth and division. When there are too many HER2 cells concentrated in a single area they can multiply too quickly leading to the development of a tumour.
The Dauntless-1 trial has one primary endpoint, examining the safety and tolerability of the combination treatment through incidences of adverse events and changes in laboratory vital signs. Other secondary endpoints will evaluate the plasma concentration of PMD-026 and preliminary anti-tumour activity.
Phoenix CEO Sandi Dunn said: “In our Phase I/Ib monotherapy study, PMD-026 demonstrated favourable tolerability, with no peripheral neuropathy, hair loss, or hyperglycaemia.
“Moreover, PMD-026 demonstrated a median progression-free survival (PFS) of 4.8 months in patients with RSK2-high tumours versus only 1.3 months in patients with RSK2-low tumours in a subset analysis of patients who had no more than five prior therapies. We believe that PMD-026 as a combination therapy represents a promising new approach to treating advanced breast cancer.”
Research by GlobalData estimates that the global market for metastatic breast cancer treatment in 2024 brought in $54bn, which is expected to rise to $61bn by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of metastatic breast cancer, nearly 70,000 women throughout the UK are set to take part in an AI-driven trial designed to advance methods of early breast cancer detection backed by £11m in government funding.
